The expanded approval was based on data from a previously announced Phase 3 study

Vertex announced that the Food and Drug Administration (FDA) has approved Orkambi (lumacaftor and ivacaftor) tablets for use in children with cystic fibrosis aged 6–11 years who have 2 copies of theF508del mutation.

Previously, Orkambi was approved for use in patients aged ≥12 years with 2 copies of the F508del mutation. The expanded approval was based on data from a previously announced open-label Phase 3 clinical safety study of Orkambi.